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    Clinical Trial Results:
    Investigation of once-weekly semaglutide s.c. dose-response in patients with type 2 diabetes and overweight - a participant- and investigator-blinded and sponsor open-label study.

    Summary
    EudraCT number
    2022-000882-41
    Trial protocol
    HU   GR   PL  
    Global end of trial date
    13 Dec 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Dec 2024
    First version publication date
    27 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9535-4984
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05486065
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Feb 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterise the dose-response curve of once weekly semaglutide s.c. for change in HbA1c from baseline to week 40 in patients with type 2 diabetes (T2D) and body mass index (BMI) ≥ 27 kg/m2 as an add-on to a stable dose of metformin.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (Oct 2013) and International Council for Harmonisation (ICH) Good Clinical Practice, including archiving of essential documents (May 1996) and European Norm (EN) International Organization for Standardization (ISO) 14155 Part 1 and 2 and Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) 312.120.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 Aug 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Greece: 54
    Country: Number of subjects enrolled
    Hungary: 35
    Country: Number of subjects enrolled
    Poland: 33
    Country: Number of subjects enrolled
    United States: 123
    Worldwide total number of subjects
    245
    EEA total number of subjects
    122
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    245
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at 82 active sites in 4 countries, of which 75 sites enrolled subjects.

    Pre-assignment
    Screening details
    Subjects were randomized at a ratio of 3:1:3:1:3:1 to receive semaglutide (2 mg, 8 mg, 16 mg) or matching placebo.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Semaglutide 2.0 mg
    Arm description
    Subjects received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg], followed by the maintenance dose of 2 mg) till 40 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly s.c. injections of semaglutide for 40 weeks.

    Arm title
    Semaglutide 8.0 mg
    Arm description
    Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg], followed by the maintenance dose of 8 mg) till 40 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly s.c. injections of semaglutide for 40 weeks.

    Arm title
    Semaglutide 16.0 mg
    Arm description
    Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg], followed by the maintenance dose of 16 mg) till 40 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly s.c. injections of semaglutide for 40 weeks.

    Arm title
    Placebo
    Arm description
    Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Semaglutide placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly s.c. injections of placebo matched to semaglutide for 40 weeks.

    Number of subjects in period 1
    Semaglutide 2.0 mg Semaglutide 8.0 mg Semaglutide 16.0 mg Placebo
    Started
    61
    62
    62
    60
    Full analysis set
    61
    62
    62
    60
    Safety analysis set
    60
    60
    62
    59
    Completed
    56
    54
    55
    54
    Not completed
    5
    8
    7
    6
         Consent withdrawn by subject
    1
    5
    4
    3
         Physician decision
    -
    1
    1
    -
         Failure to meet randomization criteria
    -
    -
    -
    1
         Lost to follow-up
    4
    2
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide 2.0 mg
    Reporting group description
    Subjects received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg], followed by the maintenance dose of 2 mg) till 40 weeks.

    Reporting group title
    Semaglutide 8.0 mg
    Reporting group description
    Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg], followed by the maintenance dose of 8 mg) till 40 weeks.

    Reporting group title
    Semaglutide 16.0 mg
    Reporting group description
    Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg], followed by the maintenance dose of 16 mg) till 40 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.

    Reporting group values
    Semaglutide 2.0 mg Semaglutide 8.0 mg Semaglutide 16.0 mg Placebo Total
    Number of subjects
    61 62 62 60 245
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    52.3 ( 7.6 ) 53.7 ( 7.5 ) 52.9 ( 8.6 ) 52.1 ( 9.5 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    27 33 25 35 120
        Male
    34 29 37 25 125
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0 0
        Asian
    1 1 0 1 3
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0
        Black or African American
    6 11 4 4 25
        White
    54 49 56 55 214
        More than one race
    0 0 2 0 2
        Unknown or Not Reported
    0 1 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    9 8 9 13 39
        Not Hispanic or Latino
    52 54 53 47 206
        Unknown or Not Reported
    0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide 2.0 mg
    Reporting group description
    Subjects received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg], followed by the maintenance dose of 2 mg) till 40 weeks.

    Reporting group title
    Semaglutide 8.0 mg
    Reporting group description
    Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg], followed by the maintenance dose of 8 mg) till 40 weeks.

    Reporting group title
    Semaglutide 16.0 mg
    Reporting group description
    Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg], followed by the maintenance dose of 16 mg) till 40 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.

    Primary: Change in glycated haemoglobin (HbA1c)

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    End point title
    Change in glycated haemoglobin (HbA1c)
    End point description
    Change in HbA1c from baseline (week 0) to end of treatment (week 40) is presented. Full analysis set included all randomised subjects. Here, "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline (week 0) and End of treatment (week 40)
    End point values
    Semaglutide 2.0 mg Semaglutide 8.0 mg Semaglutide 16.0 mg Placebo
    Number of subjects analysed
    56
    57
    56
    54
    Units: Percentage-point of HbA1c
        arithmetic mean (standard deviation)
    -1.9 ( 1.1 )
    -1.8 ( 1.5 )
    -2.1 ( 1.5 )
    -1.1 ( 1.3 )
    Statistical analysis title
    Semaglutide 2.0 mg - Placebo
    Comparison groups
    Semaglutide 2.0 mg v Placebo
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    [1]
    P-value
    = 0.0002
    Method
    ANCOVA
    Parameter type
    Treatment difference
    Point estimate
    -0.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.25
         upper limit
    -0.39
    Notes
    [1] - The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.
    Statistical analysis title
    Semaglutide 16.0 mg - Semaglutide 2.0 mg
    Comparison groups
    Semaglutide 2.0 mg v Semaglutide 16.0 mg
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    [2]
    P-value
    = 0.2445
    Method
    ANCOVA
    Parameter type
    Treatment difference
    Point estimate
    -0.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.67
         upper limit
    0.17
    Notes
    [2] - The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.
    Statistical analysis title
    Semaglutide 8.0 mg vs Semaglutide 2.0 mg
    Statistical analysis description
    The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.
    Comparison groups
    Semaglutide 2.0 mg v Semaglutide 8.0 mg
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.8305
    Method
    ANCOVA
    Parameter type
    Treatment difference
    Point estimate
    0.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.38
         upper limit
    0.47
    Statistical analysis title
    Semaglutide 16.0 mg - Semaglutide 8.0 mg
    Comparison groups
    Semaglutide 8.0 mg v Semaglutide 16.0 mg
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    [3]
    P-value
    = 0.1678
    Method
    ANCOVA
    Parameter type
    Treatment difference
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.72
         upper limit
    0.13
    Notes
    [3] - The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.
    Statistical analysis title
    Semaglutide 8.0 mg vs Placebo
    Comparison groups
    Semaglutide 8.0 mg v Placebo
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    [4]
    P-value
    = 0.0003
    Method
    ANCOVA
    Parameter type
    Treatment difference
    Point estimate
    -0.77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.19
         upper limit
    -0.35
    Notes
    [4] - The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.
    Statistical analysis title
    Sema 16.0 mg vs Placebo
    Comparison groups
    Semaglutide 16.0 mg v Placebo
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    [5]
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Treatment difference
    Point estimate
    -1.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.5
         upper limit
    -0.64
    Notes
    [5] - The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.

    Secondary: Change in body weight

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    End point title
    Change in body weight
    End point description
    Change in body weight from baseline (week 0) to end of treatment (week 40) is presented. Full analysis set included all randomised subjects. Here, "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline (week 0) and End of treatment (week 40)
    End point values
    Semaglutide 2.0 mg Semaglutide 8.0 mg Semaglutide 16.0 mg Placebo
    Number of subjects analysed
    56
    56
    55
    53
    Units: Kilogram (kg)
        arithmetic mean (standard deviation)
    -8.9 ( 8.5 )
    -10.1 ( 7.4 )
    -13.1 ( 8.4 )
    -2.3 ( 4.9 )
    No statistical analyses for this end point

    Secondary: Number of treatment-emergent adverse events (TEAEs)

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    End point title
    Number of treatment-emergent adverse events (TEAEs)
    End point description
    AE is any untoward medical occurrence in a clinical study subjects that is temporally associated with use of investigational medicinal products (IMP), whether or not considered related to IMP. AE can therefore be any unfavourable & unintended sign, symptom or disease (new/exacerbated) temporally associated with use of IMP. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment observation period is defined as time points from first drug date until first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until first date of end of study visit or date of death or date of withdrawal of informed consent or contact as defined by investigator for subjects that are lost to follow up. Safety analysis set included all subjects who are exposed to randomised treatment.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) up to end of study (week 49)
    End point values
    Semaglutide 2.0 mg Semaglutide 8.0 mg Semaglutide 16.0 mg Placebo
    Number of subjects analysed
    60
    60
    62
    59
    Units: Events
        number (not applicable)
    43
    54
    55
    37
    No statistical analyses for this end point

    Secondary: Number of treatment-emergent severe hypoglycaemic episodes

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    End point title
    Number of treatment-emergent severe hypoglycaemic episodes
    End point description
    Number of treatment-emergent severe Hypoglycaemic episodes are presented. Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. On treatment observation period data are presented. On-treatment oberservation period is defined as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until the first date of end of study visit or date of death or date of withdrawal of informed consent or date of last contact as defined by investigator for subjects that are lost to follow up. Safety analysis set included all subjects who are exposed to randomised treatment.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) up to end of study (week 49)
    End point values
    Semaglutide 2.0 mg Semaglutide 8.0 mg Semaglutide 16.0 mg Placebo
    Number of subjects analysed
    60
    60
    62
    59
    Units: Episodes
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline (week 0) up to end of study (week 49)
    Adverse event reporting additional description
    AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. Safety analysis set included all subjects who are exposed to randomised treatment.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    Sema 16.0 mg
    Reporting group description
    Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg], followed by the maintenance dose of 16 mg) till 40 weeks.

    Reporting group title
    Sema 2.0 mg
    Reporting group description
    Subjects received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg], followed by the maintenance dose of 2 mg) till 40 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.

    Reporting group title
    Sema 8.0 mg
    Reporting group description
    Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg], followed by the maintenance dose of 8 mg) till 40 weeks.

    Serious adverse events
    Sema 16.0 mg Sema 2.0 mg Placebo Sema 8.0 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 62 (1.61%)
    4 / 60 (6.67%)
    2 / 59 (3.39%)
    2 / 60 (3.33%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Incisional hernia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure chronic
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Vestibular neuronitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Sema 16.0 mg Sema 2.0 mg Placebo Sema 8.0 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 62 (80.65%)
    30 / 60 (50.00%)
    29 / 59 (49.15%)
    48 / 60 (80.00%)
    Investigations
    Glycosylated haemoglobin increased
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    3 / 59 (5.08%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    3
    1
    Lipase increased
         subjects affected / exposed
    3 / 62 (4.84%)
    3 / 60 (5.00%)
    1 / 59 (1.69%)
    2 / 60 (3.33%)
         occurrences all number
    3
    3
    2
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 60 (1.67%)
    2 / 59 (3.39%)
    3 / 60 (5.00%)
         occurrences all number
    0
    1
    2
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 60 (3.33%)
    4 / 59 (6.78%)
    6 / 60 (10.00%)
         occurrences all number
    3
    2
    5
    6
    Headache
         subjects affected / exposed
    7 / 62 (11.29%)
    2 / 60 (3.33%)
    8 / 59 (13.56%)
    6 / 60 (10.00%)
         occurrences all number
    9
    6
    23
    13
    Hyperaesthesia
         subjects affected / exposed
    5 / 62 (8.06%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    6
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    5 / 62 (8.06%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    5
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 62 (9.68%)
    2 / 60 (3.33%)
    2 / 59 (3.39%)
    4 / 60 (6.67%)
         occurrences all number
    7
    3
    2
    4
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 60 (3.33%)
    1 / 59 (1.69%)
    4 / 60 (6.67%)
         occurrences all number
    3
    3
    1
    4
    Abdominal pain upper
         subjects affected / exposed
    2 / 62 (3.23%)
    5 / 60 (8.33%)
    3 / 59 (5.08%)
    5 / 60 (8.33%)
         occurrences all number
    3
    5
    4
    6
    Abdominal pain
         subjects affected / exposed
    4 / 62 (6.45%)
    3 / 60 (5.00%)
    1 / 59 (1.69%)
    1 / 60 (1.67%)
         occurrences all number
    4
    3
    1
    1
    Diarrhoea
         subjects affected / exposed
    13 / 62 (20.97%)
    9 / 60 (15.00%)
    7 / 59 (11.86%)
    20 / 60 (33.33%)
         occurrences all number
    19
    29
    56
    30
    Dry mouth
         subjects affected / exposed
    0 / 62 (0.00%)
    3 / 60 (5.00%)
    0 / 59 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    3
    0
    2
    Dyspepsia
         subjects affected / exposed
    5 / 62 (8.06%)
    5 / 60 (8.33%)
    1 / 59 (1.69%)
    5 / 60 (8.33%)
         occurrences all number
    13
    5
    1
    5
    Eructation
         subjects affected / exposed
    5 / 62 (8.06%)
    3 / 60 (5.00%)
    1 / 59 (1.69%)
    3 / 60 (5.00%)
         occurrences all number
    8
    3
    2
    3
    Constipation
         subjects affected / exposed
    12 / 62 (19.35%)
    2 / 60 (3.33%)
    3 / 59 (5.08%)
    8 / 60 (13.33%)
         occurrences all number
    16
    2
    3
    11
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 62 (4.84%)
    1 / 60 (1.67%)
    1 / 59 (1.69%)
    4 / 60 (6.67%)
         occurrences all number
    3
    1
    1
    4
    Flatulence
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    1
    2
    0
    3
    Vomiting
         subjects affected / exposed
    16 / 62 (25.81%)
    11 / 60 (18.33%)
    4 / 59 (6.78%)
    14 / 60 (23.33%)
         occurrences all number
    32
    16
    4
    26
    Nausea
         subjects affected / exposed
    23 / 62 (37.10%)
    13 / 60 (21.67%)
    9 / 59 (15.25%)
    25 / 60 (41.67%)
         occurrences all number
    29
    17
    18
    54
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 60 (0.00%)
    4 / 59 (6.78%)
    1 / 60 (1.67%)
         occurrences all number
    2
    0
    6
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 62 (9.68%)
    1 / 60 (1.67%)
    2 / 59 (3.39%)
    0 / 60 (0.00%)
         occurrences all number
    7
    1
    4
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 60 (1.67%)
    3 / 59 (5.08%)
    8 / 60 (13.33%)
         occurrences all number
    1
    1
    3
    8
    Nasopharyngitis
         subjects affected / exposed
    3 / 62 (4.84%)
    3 / 60 (5.00%)
    2 / 59 (3.39%)
    1 / 60 (1.67%)
         occurrences all number
    3
    4
    3
    1
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 62 (8.06%)
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    5
    1
    0
    1
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    2
    0
    0
    3
    Hyperglycaemia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    4 / 59 (6.78%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    4
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    4 / 59 (6.78%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    4
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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